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Cannabis
trials start on patients

The
first clinical trials of cannabis-based medicines involving
patients suffering from MS, spinal cord injury and other
forms of severe pain have been given the go-ahead.

They
will be carried out by GW Pharmaceuticals; the company
licensed by the UK Home Office to research and develop
prescription cannabis-based medicines. If successful they
could lead to cannabis-based drugs being made widely available
within three years.

The
trials, to be conducted at a number of locations, will
begin in the Pain Relief Clinic at the James Paget Hospital,
Great Yarmouth, under the supervision of Dr Willy Notcutt.
Dr Notcutt said: "Our aim is to test some of the claims
which have been made for the medicinal qualities of cannabis
in a structured clinical research programme. This is an
exciting moment, and we hope very much that our findings
will lead to significant improvements in the pain relief
available for sufferers of MS and other debilitating conditions."

"I
have been involved in trying to get movement in this area
for many years now. It has been a long haul from the wilderness
but I am just thrilled that we have got there first, Now
I hope that this is the thing which ignites the blue touchpaper
to get these trials going all over the country. In the
last two years everyone has woken up to the fact that
cannabis used as a medicine is something that should not
be ignored and now at last we will be able to do something
about. It has been around as a medicinal drug for 5000
years but it has never been in a medicine form before.
So until this point we have not been able to do any proper
clinical tests as you cannot really use cannabis smoked
in a joint or taken orally as the basis of a clinical
trial."

Dr
Notcutt said that while some might consider the announcement
controversial, those suffering from debilitating diseases
would welcome the news who for years had asked for proper
clinical trials. He urged anti-drug campaigners to consider
the trials, which are not Government-funded, as a medical
step forward and not see them as the start of a relaxation
in current drug laws. "I don't think people can argue
this because you can prescribe heroin as a drug - and
I don't talk about heroin as a painkiller in the same
breath as heroin as a recreational substance. These trials
cannot in any way be linked with drug abuse, it is an
entirely different thing,"

He
said it was a misconception that those suffering debilitating
illnesses would receive the same feeling from the drugs
as recreational users or that they would take such high
doses. "A lot of patients are incapacitated by the pain
but they don't want to be incapacitated by taking so much
that they get high."

Tests
will be carried out using a device that sprays medicine
under the tongue so that it is absorbed by the body rather
than swallowed. Only a strictly limited number of patients
will take part in the first trials. However, it is expected
that some 2000 people will eventually take part in the
trial programme over the next two to three years.

Dr
Geoffrey Guy, announcing the launch of the licensed trials,
said the numbers of people who could have their suffering
relieved was mind-boggling and the trials would help to
establish the dose needed to relieve pain, and the best
way of delivering the drugs to patients. He said: "There
is a considerable body of evidence to suggest that cannabis
may have a number of medicinal uses, including the relief
of pain and spasm in multiple sclerosis, and for pain
relief in disorders such as spinal cord injury and neuralgia.
We are now well on the way to being able to demonstrate
this in a controlled clinical research environment."

Two
thousand patients will take part in the trials over the
next two or three years. They will spray the cannabis
under the tongue from where it will be absorbed quickly
into the system.

"We
hope to demonstrate to the authorities the safety and
efficacy of the medicine," said Dr Guy. "There are patients
who will benefit from these medicines but who would not
think of taking cannabis if they had to break the law."

GW
has already completed preliminary trials in which a small
group of subjects took different cannabis preparations
to determine the safe range of dose. GW has set up a database
for patients who may be suitable for participation in
clinical trials.

The
government has indicated that if the trials were successful
it would be prepared to amend the Misuse of Drugs Act
1971 to allow the prescribing of a cannabis-based medicine.
GW hopes to market prescription medicines as early as
2003.

The
Medical Research Council is also about to conduct trials
on cannabis. Neurologists will use different compounds
of cannabis in capsule form.

It
is estimated that 10,000 people suffering acute pain and
distress take cannabis illegally. One of them is 52-year-old
Elizabeth Ivol. She and 8,000 other MS sufferers regularly
use cannabis in defiance of the law. She risked jail three
years ago when she was caught growing marijuana at her
home in the Orkneys but escaped with an admonishment.

Since
then she has continued to use the drug and to supply it
to other sufferers. She said yesterday: "There is a huge
network of people who are using cannabis and helping each
other get the drug. One of the favourite ways of taking
it is in melted chocolate. It controls my pain, which
is otherwise unbearable. One thing that happens to me
is that my eyesight goes. I only need to smoke cannabis
and my vision is restored."

There
are 85,000 people suffering from multiple sclerosis and
45,000 with spinal cord injury - two conditions being
targeted in the trials.

Labour
MP Paul Flynn, who has a Bill to legalise medicinal cannabis
coming before the Commons, said: "I'm sure the trials
will be successful. Cannabis was even used by the Egyptians
who built the pyramids."

The
prospect of the government legalising the use of cannabis
for medicinal purposes is still at least two to three
years away.

Geoffrey
Guy, chairman of GW Pharmaceuticals, has two Home Office
licences to research the medical uses of the drug, said
the company had completed the first human trials in November.

The
company is testing a cannabis-based prescription medicine
that would give patients the medical benefits of dope
but without the "unwanted psychoactive side effects" -
or the high - and without the health dangers associated
with smoking.

Downing
Street and the Home Office rejected reports yesterday
that a deal had been struck between Tony Blair, Mo Mowlam
and Jack Straw that the use of cannabis for medicinal
purposes would be given the go-ahead later this year.

The
cabinet office minister wanted a government-ordered review
of whether cannabis should be decriminalised while the
home secretary is adamantly opposed to any relaxation
of the drug laws.

Downing
Street reiterated yesterday that the Prime Minister was
waiting to see the results of the clinical trials before
any decision was arrived at.

Dr
Guy said that the newspaper reports had simply confirmed
the "government's long-held view that it intends to allow
cannabis-based medicines to be prescribed to patients
once clinical trials are completed.

"GW's
trials aim to demonstrate quality, safety, and efficacy
to the satisfaction of the medicines control. The reports
provide further reassurance that once MCA approval is
obtained for cannabis-based medicines, the government
will reschedule these products so as to allow prescription
use."

The
Home Office minister, Lord Williams, told the company
early in 1998 that "if and when the benefits of cannabis-based
medicine are scientifically demonstrated... the government
would be willing to propose an amendment to the misuse
of drugs legislation to allow the prescription of such
medicine."

A
Home Office spokesman confirmed yesterday that the policy
had not changed.

GW
Pharmaceuticals grew its first crop of 5,000 cannabis
plants last summer in a secret greenhouse in the south
of England. It eventually hopes to grow 20,000 plants
at the site, which is being guarded around the clock.

The
powder from the plants will be made into capsules or given
to patients using an inhaler.

American
reports

By
cultivating marijuana and testing the most promising of
its more than 100 ingredients, GW hopes to develop drugs
for a variety of ailments, a company official said at
the first national conference for health professionals
on the medical uses for marijuana.

The
privately owned company, GW Pharmaceuticals Ltd, is ''trying
to turn an illegal plant into a pharmaceutically regulated
product'' by developing cannabis-based medicines that
are not smoked, said Dr. David C. Hadorn, the company's
North American medical director. GW is studying what it
believes will be the most promising ingredients of marijuana
in a structured research program.

Full-scale
testing eventually will involve about 2,000 patients in
England, Canada and the United States, and the hope is
to develop a licensed product by 2003, Hadorn said.

The
University of Iowa's colleges of nursing and medicine
sponsored the two-day conference to help health care professionals
and providers learn how to obtain and properly use medical
marijuana.

Melanie
C. Dreher, the nursing school's dean, said the conference
was needed because thousands of Americans use marijuana
medically even though it is illegal in most states. Voters
in at least seven states (Alaska, Arizona, California,
Colorado, Nevada, Oregon and Washington) have approved
initiatives intended to make marijuana legal for medical
purposes. But many doctors are afraid to recommend it
because the federal government has threatened to prosecute
them.

No
government officials were among the 250 patients, doctors,
nurses and lawyers who attended the conference and at
telecasts in seven medical centers in the United States
and Canada. Dr. David Satcher, the Surgeon General of
the Public Health Service, declined an invitation.

"The
challenge is to quit using illegality as an excuse not
to discuss medical marijuana," said Mary Lynn Mathre,
an addictions nurse at the University of Virginia and
co-director of the Iowa conference.

With
her husband, Al Byrne, Ms. Mathre founded Patients Out
of Time; a non-profit group based in Virginia that promotes
the legal use of medical marijuana and that helped organise
the conference.

In
a government-commissioned study a year ago, the Institute
of Medicine of the National Academy of Sciences said that
some of the ingredients in marijuana were potentially
effective in treating pain, nausea and severe weight loss
from AIDS. The institute also urged rigorous testing of
marijuana for other ailments.

Dr.
Hadorn of GW Pharmaceuticals said his company was concentrating
on eight principal ingredients of marijuana. The amount
of these ingredients, which are members of the cannabinoid
group, varies in each naturally grown plant. To standardise
the amounts, GW has cloned, cultivated and harvested tens
of thousands of marijuana plants, in a greenhouse at a
secret location in England.

"We
are the only people in the world licensed to grow pharmaceutical-grade
cannabis," Dr. Geoffrey Guy, who founded GW Pharmaceuticals
in December 1997, said in a telephone interview today.
He added that the National Institute on Drug Abuse in
the United States grows marijuana, but that it is not
standardised for pharmaceutical grade.

By
cultivating cannabis under highly controlled indoor conditions,
GW hopes to satisfy criteria set by the Food and Drug
Administration and similar governmental agencies world-wide
so it can eventually market the most effective combination
of ingredients as prescription drugs. Dr. Guy estimated
that it would cost at least $16 million to market the
first marijuana product.

To
avoid the dangers associated with smoking, GW Pharmaceuticals
aims to develop non-smoke delivery systems like inhalers
and nebulizers. The company is starting with products
that are absorbed after being sprayed under the tongue
and is initially concentrating on the components known
as THC (tetrahydrocannabinol) and CBD (cannabidiol), Dr.
Hadorn said.

GW
Pharmaceuticals hopes to start testing on a small number
of people in the United States later this year, Dr. Guy
said. The company has held discussions with all appropriate
American agencies, but Dr. Guy declined to say where the
tests would be conducted.

Dr.
Juan Sanchez-Ramos of the University of South Florida
in Tampa said he learned about GW's efforts at the meeting.
He said he hoped eventually to determine whether an ingredient
of marijuana could help in Parkinson's disease by controlling
the unwanted constant twisting movements that often develop
among users of a drug called L-Dopa. Dr. Sanchez-Ramos
said Parkinson's disease patients who claimed relief after
smoking marijuana gave him the idea of studying the drug
for that condition.